MAUDE Adverse Event Report: PERFUSION SYSTEMS EOPA ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 77424

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Unspecified Infection (1930); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)

Event Date 10/01/2014

Event Type  Injury  

Manufacturer Narrative

Literature citation: biscotti, m.And bacchetta, m., 2014.The ¿sport model¿: extracorporeal membrane oxygenation using the subclavian artery.The annals of thoracic surgery, 98(4), pp.1487-1489.Doi.Org/10.1016/j.Athoracsur.2014.02.069 b3: the publication date has been used as the event date.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a study on a technique for subclavian artery cannulation to provide a safe and durable means of veno-arterial extracorporeal membrane oxygenation (ecmo) support.All data were collected from a single center.The study population included 30 patients.An 18 or 24 fr eopa arterial cannulae and a 23 fr bio-medicus jugular venous cannula were used on patients in this study.Among all patients, 14 deaths occurred.Six patients died during ecmo, and 8 patients died after ecmo decannulation.It was stated that all patients in this study were critically ill with either respiratory, cardiac, or combined cardiopulmonary failure.It was also stated that using the subclavian artery technique, sufficient flows, adequate gas exchange, and ventricular unloading confirmed by echocardiography were achieved.Right subclavian artery ecmo cannulation was uneventful in this population.Based on the available information, none of the deaths were attributed to the medtronic products.Among all patients, adverse events included: 1 patient had a cannula site infection, 11 patients had cannula site hematomas, 4 had i psilateral limb swelling, and 2 had cannula thrombosis.It was stated that the 2 patients in this series with cannula thrombosis were obese, and the author's suspect cannula kinking to be causal.Based on the available information, these adverse events may have been attributed to the medtronic products.Among all patients, device malfunctions included: cannula kinking.Based on the available information, this malfunction may have been attributed to the medtronic products.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Conclusion: medtronic cannot confirm or deny the complaint of cannula site infection, hematomas, limb swelling and thrombosis during subclavian artery cannulation veno-arterial extracorporeal membrane oxygenation (ecmo) support as no product has been returned to date.A root cause of this occurrence cannot be determined without returned product.A clinical review was completed with medtronic medical safety and review concluded none of the adverse events reported directly contributed to patient mortality.Additionally, all patients in this study were critically ill with either respiratory, cardiac, or combined cardiopulmonary failure and patient mortality may have been a result of these underlying conditions.None of the medtronic devices mentioned in this article are available for evaluation.During the time period reported in the literature article, the bio-medicus nextgen one-piece femoral arterial / jugular venous cannula and eopa arterial cannula were only ¿intended for use up to 6 hours¿ (refer to instructions for use (ifu) for bio-medicus nextgen and for eopa) and use beyond 6 hours would be considered off-label.All of the adverse events and device malfunctions reported in this literature are not new or unexpected adverse event or device malfunctions associated with the use of these cannula devices and are predicted as known or foreseeable risks within risk management documentation.The device history record could not be reviewed as no lot number was provided.Complaints received from october 2014 through february 2023 for similar model numbers were reviewed and showed no trends warranting escalation related to this occurrence.Medtronic will continue to monitor for future occurrences and trends.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EOPA ARTERIAL CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15779649
• MDR Text Key: 303573247
• Report Number: 2184009-2022-00304
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 77424
• Device Catalogue Number: 77424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2022
• Initial Date FDA Received: 11/11/2022
• Supplement Dates Manufacturer Received: 02/15/2023
• Supplement Dates FDA Received: 03/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization